Cepheid Receives FDA Clearance for Norovirus Diagnostic

Norovirus is a highly contagious virus and is the most common cause of viral gastroenteritis worldwide, infecting approximately 267 million people and causing over 200,000 deaths annually. A newly approved on-demand molecular test from Cepheid provides accurate norovirus detection in as little as one hour.

The company this week announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market the test, called Xpert Norovirus, which is a qualitative in vitro diagnostic test for expeditious identification and differentiation of Noroviruses genogroup I (GI) and genogroup II (GII).

All Xpert tests run on Cepheid’s GeneXpert System, which has an install base of more than 7,500 systems worldwide.

“Norovirus exposure is an unfortunate fact of life. The associated illness can spread quickly in the hospital setting and be very serious, especially in young children and older adults,” said John Bishop, Cepheid’s Chairman and Chief Executive Officer. “To actively manage the infection, clinicians have previously been forced to choose between accuracy and time-to-result when selecting a testing method — now no compromise is required as Xpert Norovirus delivers both.”

“Xpert Norovirus enables on-demand molecular detection and differentiation of the GI and GII Norovirus genogroups, which together account for the vast majority of human infections,” said Dr. David H. Persing, MD, Ph.D., Cepheid’s Chief Medical and Technology Officer. “Norovirus outbreaks require immediate implementation of targeted infection control procedures, and this new test gives clinicians accurate results in as little as one hour.”